Site Activation Specialist (m/f/d)

Site Activation Specialist (m/f/d)- Study Start-up/CRO Management/Clinical Trail Planning/IRB/Ethic Committee/Clinical trail methodologies/Medical Methodologies/ICH/GCP/English

Project: For our customer a big Diagnostic company in Rotkreuz, Zug we are looking for a qualified Site Activation Specialist (m/f/d)

Background:
The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.

The Perfect Candidate:
The ideal candidate possesses a Bachelor's degree in life sciences and extensive study start-up experience, including proficient knowledge of CRO management and global regulatory submissions (IRB/EC, Competent Authorities). They must have a strong working knowledge of ICH/GCP and global regulations like IVDR, coupled with the ability to organize and multi-task effectively to drive timely site activation deliverables across multiple regions. This individual is a fluent English speaker who excels at cross-functional collaboration, ensuring all regulatory documentation, contracts, and logistics are completed with attention to detail and quality.

Tasks & Responsibilities:
? Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects.
? Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information.
? Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner
? Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements
? Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams
? Work with sites to ensure informed consent form meets the required regulatory and company requirements.
? Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC.
? Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study.
? Support contract and budget negotiations in partnership with Contracting and Study Teams.
? Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up.
? Support study instrument placements, Obtain import/export licensure
? Support implementation and use of eTools at the site
? Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use
? Work closely with Study Teams to deliver study start-up tasks.
? Solve identified issues with appropriate timely escalation to the Study Teams
? Support internal audit and external inspection activities; contribute to CAPAs as required.
? May be responsible for other responsibilities as assigned.

Must Haves:
? Associate or Bachelor's degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
? Experience in study start-up is required
? Experience with CRO management.
? Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
? Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
? Must be fluent in English
? Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations).
? Understand the quality expectations and emphasis on the right first time, attention to detail
? Ability to organize tasks, time, and priorities, ability to multi-task
? Required to support multi-national team members, and flexibility in working hours may be needed.
?Participate and work effectively with multiple cross-functional teams

Nice to haves:
?Any additional language

Reference No .: 924558
Role: Site Activation Specialist (m/f/d)
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: January 1st, 2026 (Latest Start date: February 1st, 2026)
Duration: 12months +
Deadline: November 13th, 2025

If you are interested in this position, please send us your complete dossier via the link in this advertisement.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.